Atherosclerotic disease of the carotid artery is almost exclusively located at the level of the common carotid bifurcation and often extends into the internal carotid artery. Atherosclerotic narrowing of the carotid artery often leads to stroke, which is one of the leading causes of death in North America and one of the major causes of long-term disability. Carotid Endarterectomy (CE) is the surgical procedure where the surgeon opens the diseased carotid artery and physically removes the plaque of atherosclerosis, thus reestablishing a normal caliber of the vessel and normal blood flow to the brain. There is early evidence, both in Europe and in North America, that balloon angioplasty of the carotid artery followed by carotid stenting can in fact open the narrowed and diseased artery. The role of the stent is to maintain long-term patency of the artery following angioplasty and to avoid long-term restenosis.
One of the major technical difficulties encountered in balloon angioplasty in the carotid circulation artery is the fact that the passage through the atherosclerotic artery is so small that area of stenosis often needs to be predilated with a small and low profile balloon in order to be able to position the stent delivery device and to deliver a self expandable stent at the desired location of the stenosis. The need to predilate the artery necessitates the passage of a low profile balloon through the area of stenosis, dilatation of the artery, and removal of the predilatation balloon, followed by passage of the stent deployment device through the same area of stenosis. This manipulation of the balloon and then the stent within the narrowed artery, which contains irregular and friable plaque, can cause thromboembolic complications. For example, dislodgment of a fragment of plaque can cause a stroke if it is not caught before it passes into the brain.
Hence, it is desirable to provide a device that requires minimal manipulation within the area of stenosis. It is further desired to provide a device that is capable of preventing any fragments of plaque that may become dislodged from passing up through the artery and into the brain.